Efforts to Improve Research on Kids' Drugs Paying Off: Report
But information still limited on long-term safety, efficacy, especially for infants
WEDNESDAY, Feb. 29, 2012 (HealthDay News) -- Federal laws requiring medical companies to conduct pediatric drug studies have helped provide guidance on whether it's safe or effective for children to use certain medications, a new U.S. report finds.
The Institute of Medicine (IOM) report noted, however, that there's still not enough data on the use of drugs in newborns or the long-term effects of drugs on kids generally. The IOM, part of the National Academies, is an independent, nonprofit organization that provides advice to U.S. policymakers, health professionals, industry and the public.
Congress has attempted to increase the number of pediatric studies of medications with the passage of two laws: the Best Pharmaceuticals for Children Act, which offers companies financial incentives to conduct the studies; and the Pediatric Research Equity Act, which requires pediatric studies in specific situations.
In reviewing these laws, which are due for reauthorization this year, the IOM committee found that both laws have had a positive effect on the use of drugs in children. The committee noted, however, that the laws could be more effective if the U.S. Food and Drug Administration used its authority to require that drug makers undertake long-term follow-up studies after products have been approved for sale.
Long-term studies are especially important for young patients because children's bodies and minds are not fully developed and they could be taking medications for chronic conditions over the course of many years, the report stated. The IOM committee added that newborns are also more vulnerable to the side effects of medications.
The report, released Feb. 29, concluded that Congress and the FDA could step in to improve research in these areas and force drug manufacturers to conduct timely long-term studies on the risk of medications among children or face penalties. This may be necessary, the report authors suggested in a news release from the National Academy of Sciences, because conducting research on children is more difficult and often yields less lucrative results than studies involving adults.
The Nemours Foundation has more about understanding medications.